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Nordic Luveris Study

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ClinicalTrials.gov Identifier: NCT00553293
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : November 5, 2007
Sponsor:
Collaborators:
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Information provided by:
Rigshospitalet, Denmark

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Condition or disease Intervention/treatment Phase
Infertility In Vitro Fertilization Drug: recombinant luteinizing hormone (Luveris) Drug: recombinant follicle stimulating hormone (Gonal-f) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial
Study Start Date : August 2003
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A,1
rFSH + rLH arm
 Drug: recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
Other Name: Luveris
Placebo Comparator: A,2
rFSH alone
 Drug: recombinant follicle stimulating hormone (Gonal-f)
rFSH 150 iu/day
Other Name: Gonal-f


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy rate per started stimulation cycle [ Time Frame: ultrasound showing ongoing pregnancy ]

Secondary Outcome Measures :
  1. Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ Time Frame: ultrasound for ongoing pregnancy in subgroups ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age below 40
  • Infertility treatable by IVF or ICSI
  • Regular cycles

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553293


Locations
Denmark
Anders Nyboe Andersen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Investigators
Principal Investigator: Anders N Andersen, professor Fertility Clinic Rigshospitalet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00553293     History of Changes
Other Study ID Numbers: KF02-035/03
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: November 5, 2007
Last Verified: November 2007

Keywords provided by Rigshospitalet, Denmark:
infertility
in vitro fertilization
LH supplementation
Benefits

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
 Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs